Ignite Creation Date:
2024-05-06 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05338892
Status:
COMPLETED
Last Update Posted:
2023-10-19
First Post:
2022-04-14
Brief Title:
Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for RelapsedRefractory Diffuse Large B-Cell Lymphoma
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
Outcomes in Patients With RelapseRefractory Diffuse Large B-Cell Lymphoma Treated With Systemic Therapy From Real-World Experience ORCHID
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORCHID
Brief Summary:
Primary Objective
To evaluate objective response rate ORR in adult patients with RelapsedRefractory Diffuse Large B-Cell Lymphoma rr DLBCL who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma Cheson 2014 and as assessed by independent central review
Secondary Objectives
To evaluate the following outcomes in adult patients with rr DLBCL who are treated with currently available therapies in the real-world setting
1 ORR according to Lugano classification and as assessed by treating physician evaluation
2 Complete Response CR rate according to Lugano classification and as assessed by
Independent central review and
Treating physician evaluation
3 Progression Free Survival PFS according to Lugano classification and as assessed by
Independent central review and
Treating physician evaluation
4 Overall Survival OS
5 Duration of response DOR according to Lugano classification and as assessed by
Independent central review and
Treating physician evaluation
6 Disease control rate DCR according to Lugano classification and as assessed by
Independent central reviewed
Treating physician evaluation
7 Time to next treatment TTNT
To evaluate objective response rate ORR in adult patients with RelapsedRefractory Diffuse Large B-Cell Lymphoma rr DLBCL who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma Cheson 2014 and as assessed by independent central review
Secondary Objectives
To evaluate the following outcomes in adult patients with rr DLBCL who are treated with currently available therapies in the real-world setting
1 ORR according to Lugano classification and as assessed by treating physician evaluation
2 Complete Response CR rate according to Lugano classification and as assessed by
Independent central review and
Treating physician evaluation
3 Progression Free Survival PFS according to Lugano classification and as assessed by
Independent central review and
Treating physician evaluation
4 Overall Survival OS
5 Duration of response DOR according to Lugano classification and as assessed by
Independent central review and
Treating physician evaluation
6 Disease control rate DCR according to Lugano classification and as assessed by
Independent central reviewed
Treating physician evaluation
7 Time to next treatment TTNT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None